Cambridge Laboratories drug gets FDA approval

British Isles-based Cambridge Laboratories has announced that the US Food and Drug Administration (FDA) has approved one of its new products.

Prestwick Pharmaceuticals, US licensee of Xenazine, said that it has been approved by the FDA and has been given conditions for the drug’s entry onto the market.

Intended as a treatment for chorea related to Huntington’s disease, Xenazine has still to pass a public meeting of the peripheral and central nervous system advisory committee before final go-ahead.

However, Mark Evans, Cambridge Laboratories’ chief executive officer, said: “We are delighted that Xenazine is progressing towards commercialisation in the US on the back of very encouraging phase III data reported earlier in the year.”

The drug is currently marketed in the UK and Ireland by Cambridge Laboratories and by other partners around the world.

Xenazine is said to work by inhibiting vesicular monoamine transporter two and the company claims it is the first in the US to file a new drug to treat chorea in Huntington’s disease.

Around 30,000 US patients are said to be affected in the face and limbs by this disease, something which the newly-approved drug intends to treat.

© Adfero Ltd